AU745168B2 - Occlusion device - Google Patents
Occlusion device Download PDFInfo
- Publication number
- AU745168B2 AU745168B2 AU86384/98A AU8638498A AU745168B2 AU 745168 B2 AU745168 B2 AU 745168B2 AU 86384/98 A AU86384/98 A AU 86384/98A AU 8638498 A AU8638498 A AU 8638498A AU 745168 B2 AU745168 B2 AU 745168B2
- Authority
- AU
- Australia
- Prior art keywords
- occlusion device
- barrier
- artery
- occluding
- occlusion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
- 210000001367 artery Anatomy 0.000 claims description 42
- 230000004888 barrier function Effects 0.000 claims description 32
- 238000007789 sealing Methods 0.000 claims description 15
- 238000011144 upstream manufacturing Methods 0.000 claims description 12
- 239000000463 material Substances 0.000 claims description 11
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 7
- 238000004873 anchoring Methods 0.000 claims description 3
- LYXFCGCYJQCSRL-UHFFFAOYSA-N OOSO Chemical compound OOSO LYXFCGCYJQCSRL-UHFFFAOYSA-N 0.000 claims 1
- 239000008280 blood Substances 0.000 description 12
- 210000004369 blood Anatomy 0.000 description 11
- 239000004753 textile Substances 0.000 description 7
- 238000003780 insertion Methods 0.000 description 4
- 230000037431 insertion Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 239000004744 fabric Substances 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- 238000011065 in-situ storage Methods 0.000 description 3
- 229920000728 polyester Polymers 0.000 description 3
- 206010002329 Aneurysm Diseases 0.000 description 2
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 2
- 210000003484 anatomy Anatomy 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 238000009954 braiding Methods 0.000 description 2
- 230000015271 coagulation Effects 0.000 description 2
- 238000005345 coagulation Methods 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 210000003090 iliac artery Anatomy 0.000 description 2
- 238000012276 Endovascular treatment Methods 0.000 description 1
- 206010064601 Iliac artery occlusion Diseases 0.000 description 1
- 229910000990 Ni alloy Inorganic materials 0.000 description 1
- 229910001069 Ti alloy Inorganic materials 0.000 description 1
- 208000002223 abdominal aortic aneurysm Diseases 0.000 description 1
- 208000007474 aortic aneurysm Diseases 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 238000009998 heat setting Methods 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000009940 knitting Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 238000009941 weaving Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Description
OCCLUSION DEVICE This invention relates to surgical implant particularly, but not exclusively, for the occlusion of an iliac artery as part of the endovascular treatment of an abdominal aortic aneurysm.
The Ivancev-Malm6 system of endovascular aneurysm exclusion is based on a tapered aortoiliac prosthesis in conjunction with a femorofemoral bypass and a contralateral common iliac artery occlusion. Many different forms of io occlusion device have been in clinical use, but they tend to be based on a Co•closed-ended stent-graft, comprising a fabric bag and a cylindrical Gianturco Z stent. Devices have been used with the stent closed at both ends and also *o closed at only one end. However, the pelvic anatomy forces the common iliac artery into a tortuous path which makes it highly likely that the artery will be curved in two or three dimensions at the point where the occlusion device is deployed. The bending stiffness of the cylindrical stent used as the base of the occlusion device prevents both ends of the device forming a seal across the artery resulting in the leakage of arterial blood into the aneurysm.
S• 20 The object of this invention is to provide an occlusion device that attempts to 0 0 see prevent the flow of blood in an artery irrespective of the curvature of the artery.
According to an aspect of the present invention, there is provided an occlusion device for an artery comprising an elongate central section, an occluding 68 00 25 barrier at one end of the central section and means for anchoring the device in an artery, wherein the central section is sufficiently flexible to allow the barrier to be orientated by the artery wall such that the barrier is perpendicular to the long axis of the artery.
Preferably, the device includes means for urging the anchor means into position. This means may comprise, for example, a portion of the anchor means itself, a portion of the means for retaining orientation or a further component.
-ita WO 99/07292 PCT/GB98/02344 2 In preferred embodiments, the anchor means and the orientation retaining means at least are configurably coupled. The main components can be made of a shape memory alloy or other suitable material such that they can adopt a collapsed condition for the purposes of placement and automatically expand thereafter. At least an upstream occluding barrier may form a concave face spanning the internal walls of the artery when the device adopts the expanded condition.
The occluding barrier diameter when the device is in the expanded condition is typically greater than 4 or 5 mm and can be much higher. The overall geometry of the device is preferably one in which the ratio of the length to the occluding barrier diameter is at least 2:1 but not more than about 10:1. A preferred ratio would be between about 3:1 to 8: 1.
The sealing properties of the occluding barriers can be improved by providing them with a skirt of sealing elements of a material such as polyester known to encourage coagulation and light enough to be moved by leaking blood. Such skirts are most effective at downstream occluding barriers.
Preferred occlusion devices comprise a supporting structure having main components constructed from shape memory alloy (SMA) such as Nitinol which is a 50:50 alloy of titanium and nickel with a flexible occluding material such as a textile fabric or polymer sheet. The flexible occluding material may be used to form a complete surface covering of the supporting structure and/or to form at least one but preferably two barriers which are preferably held across the entire internal cross-sectional area of the artery by the supporting structure. The preferred location for the occluding barriers is at either end of the occlusion device where the barriers form end caps.
The preferred supporting structure can conform to the curvature of the artery in two ways: the central section may be recessed or absent to give room for the apex of the WO 99/07292 PCT/GB98/02344 3 curved wall of the artery and/or the central section may be sufficiently flexible to allow the end caps of the occlusion device to be orientated by the artery wall such that both end caps are perpendicular to the long axis of the artery.
The flexible occluding component of the occlusion device may be of polyester or any suitably strong flexible and biocompatible material and may be formed using weaving, knitting, braiding or embroidery.
The attachment of the end caps to the supporting structure may be by any secure mechanical system such as suturing or by passing the wires of the supporting structure through the end caps.
The supporting structure and/or the flexible occluding material may be surface treated to improve their strength, fatigue resistance, biocompatibility or blood coagulation properties.
The preferred occlusion device is able to be inserted through a sheath and then preferably open out into its expanded state without the assistance of additional devices such as balloon catheters. This may be achieved using SMA by the heat setting of the supporting structure in its final state. Once cooled, the device can be compressed sufficiently to facilitate endovascular introduction preferably using a cooled introducing sheath. Once deployed, it is preferable that body temperature is sufficient-to trigger a return to the memorised shape.
According to one embodiment of this invention, the occlusion device comprises a single braided supporting structure that has an hour-glass shape when expanded and end caps to prevent the flow of blood.
WO 99/07292 PCT/GB98/02344 4 According to a second embodiment of this invention, the framework of the occlusion device comprises a pair of essentially cone-shaped supporting structures that have a flexible link joining them in the region of the apex of the cones.
According to a third embodiment of this invention, the framework of the occlusion device comprises a pair of cone-shaped supporting structures that are interconnected at the apex of the cones.
According to a, fourth embodiment of this invention, the occlusion device comprises a pair of cylindrical sterns linked by a flexible section of supporting material or linked just by a continuation of the textile sheath covering the sterns.
According to another aspect of the present invention there is provided a skirt comprising sealing members light enough to be moved by leaking blood.
In this example, the skirt is provided around the sealing surface of the or each occluding barrier. The sealing members are moved so as to become tangled in the region of the sealing surface between the occluding barriers and the artery walls.
Preferably, the sealing members comprise polyester or another suitable material with recognised coagulation enhancing properties.
In another aspect of this invention, an additional structure, in the form of a ring of multiple strands of a flexible material, is attached to the edge of the downstream end cap of the occlusion device. The flexible strands may be individual strands of wire or texti-le or be narrow strips of textile fabric.
The strands preferably lie parallel to the device during insertion in order to minimise bulk. However, if blood should leak around the upstream end cap of the occlusion device, the flow of blood will tend to catch the free end of the flexible strands and WO 99/07292 PCT/GB98/02344 push them towards the downstream end of the device. Any points of leakage around the downstream end cap will tend to be self-sealed by the effect of the flow of blood entangling the strands on the upstream side of the leak.
This aspect of the invention relates not only to occluding devices such as the subject of the first aspect of this invention but also to vascular prosthesis and stent devices.
According to another aspect of the present invention there is provided an occlusion device comprising first and second substantially cylindrical occluding barrier elements which are configurably coupled.
The invention, and its use, will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is a view of a standard cylindrical occlusion device of the type in current clinical use, seen in situ within a curved artery- Figure 2 is a view of an embodiment of this invention, seen in situ within a curved artery Figure 3 is a view of a first embodiment of this invention comprising a single braided supporting structure in an hour-glass configuration with textile end caps 7) and retaining spikes at the downstream end of the device Figure 4 is a view of the embodiment shown in Figure 3 in its insertion state.
Figure 5 is a view of a second embodiment of this invention comprising a pair of essentially cone-shaped supporting structures (14) with a flexible link at the apex of the cones LL~~s WO 99/07292 PCT/GB98/02344 6 Figure 6 is a view of a third embodiment of this invention with a pair of cone-shaped supporting structures that are interconnected at the apex of the cones.
Figure 7 is a plan view of one of the individual V-shaped wire struts (16) used in the construction of the embodiment shown in Figure 6.
Figure 8 is a view of a fourth embodiment of this invention with a pair of cylindrical stents (19) linked by a continuation of the textile sheath (20) covering the stents.
Figure 9 is a view of the second aspect of the invention with the sealing strips (22) in the waisted section of the occlusion device Figure 10 is a view of the sealing strips (22) shown in Figure 9 following a leak.
In Figure 1, there is an illustration of the lack of conformity between the standard cylindrical occlusion device of the type in current clinical use, and the internal anatomy of a curved artery The end caps are not perpendicular to the long axis of the artery the curvature of which is holding the end caps away from the artery wall resulting in unacceptable leakage.
In Figure 2, an embodiment of this invention is seen in situ within a curved artery Occluding barriers are provided in the form of end caps 7) one of which (6) is provided on an anchor means and the other of which is provided on an orientation retaining means The means for retaining orientation also functions as a means for intercepting impinging blood and transferring the force to the anchor means to urge it into place within the artery. The waist of the occlusion device prevents the end caps 7) being pushed away from the wall of the artery while the flexible nature of the waisted section allows the artery to WO 99/07292 PCT/GB98/02344 7 automatically orientate the end caps 7) such that they lie perpendicular to the long axis of the artery and are in optimum contact with the artery wall.
In Figure 3, a preferred embodiment of this invention is shown comprising a single braided supporting structure in an hour-glass configuration formed of two conical portions with textile end caps 7) and retaining spikes at the downstream end of the device The retaining spikes are formed by a continuation of the wires forming the supporting structure beyond the downstream end cap These spikes are angled slightly outwards to engage the inner wall of the artery. The greater the blood pressure on the upstream end cap the better the engagement of the spikes into the artery wall although the depth of penetration of the spikes is limited by the position of the end cap itself. In this embodiment, there are no spikes at the upstream end of the occlusion device (11) and the braiding technique utilised provides closed loops of wire (12) rather than free ends. These loops (12) provide ideal location points for the secure mechanical attachment of the upstream end cap Although the embodiment shown in Figure 3 has two end caps the same supporting structure could be used with either one end cap and/or a complete surface covering of flexible occlusion material in addition to the end caps. The occluding barrier at the upstream end of the device (end cap 6) provides a substantially concave barrier to blood flow.
In Figure 4, the embodiment shown in Figure 3 can be seen in its insertion state.
The braided supporting structure has been cooled and then crushed into a compact cylindrical shape. Before the crushing of the supporting structure, the centre of each end cap 7) was pulled out beyond the supporting structure in order to minimise the bulkiness of the device in the delivery sheath (13).
At least the upstream occluding barrier end cap 6) should form a concave surface when the device is in place in the artery in its expanded state. Such concave WO 99/07292 PCT/GB98/02344 8 surfaces stem and redirect the blood flow while minimising turbulence and other disruptive effects.
In Figure 5, a second embodiment of this invention is shown comprising a pair of essentially cone-shaped supporting structures (14) with a flexible link (15) at the apex of the cones. The supporting structure for the cones may be braided. The flexible link (15) may be a single wire loop such that the cones (14) are held with the apex of the cones pointing along the long axis of the artery but with sufficient flexibility that each cone can be orientated independently to ensure that the end caps produce the optimum seal across the artery.
In Figure 6, a third embodiment of this invention is shown with a pair of coneshaped supporting structures that are interconnected at the apex of the cones. Each cone-shaped supporting structure is formed from a number of V-shaped struts (16) with circumferential supporting wires The use of SMA wire for the V-struts ensures that the force acting on the internal wall of the artery is a constant irrespective of the diameter of the artery. Thus, the structure acts as an effective anchor to secure the device in place within the artery. This feature applies to all embodiments shown.
In Figure 7, a plan view is shown of one of the individual V-shaped wire struts (16) used in the construction of the embodiment shown in Figure 6. The strut (16).
including the internal attachment loops is formed from an individual SMA wire.
The provision of the loops (18) facilitates the secure attachment of the circumferential supporting wires (17).
In Figure 8, a fourth embodiment of this invention is shown with a pair of cylindrical stents (19) linked by a continuation of the textile sheath (20) covering the stents (19).
This embodiment is most similar to the devices in current clinical use but the central WO 99/07292 PCT/GB98/02344 9 gap in the supporting structure makes the device sufficiently flexible for the artery to orientate the individual stents (19) such that the end caps (21) are perpendicular to the long axis of the artery.
In Figure 9, another aspect of this invention is illustrated. A skirt of sealing strips or wires or threads (22) is attached to the downstream edge of the occlusion device During insertion and initial deployment, the sealing strips (22) are located in the waisted section of the occlusion device with the maximum number of strands or strips to take advantage of the available space.
The sealing elements are light enough to be moved by leaking blood and end up tangled at the interface between the end cap 7 and the artery wall. This type of sealing device is most effective at downstream occluding barriers but may also be used at upstream occluding barriers.
In Figure 10, the effect is illustrated of a leak around the edge of both the upstream and downstream end caps The flow of blood past the waisted section of the occlusion device has caught the free upstream end of the sealing strips (23) which have then been pushed in the direction of the leak around the edge of the downstream end cap This automatically provides additional material precisely where it is required in order to eliminate the leak by plugging the gap between the end cap (7) and the artery wall (24).
In the embodiments described, the ratio of the overall length of the device to the diameter of the occluding barrier is between 2:1 and 10:1. This ratio need only be sufficient to prevent the device tumbling within the artery under the pressure of the -blood flow. The ratio is preferably between about 3:1 and 8:1.
Claims (9)
1. An occlusion device for an artery comprising an elongate central section, an occluding barrier at one end of the central section and means for anchoring the device in an artery, wherein the central section is sufficiently flexible to allow the barrier to be orientated by the artery wall such that the barrier is perpendicular to the long axis of the artery.
S2. An occlusion device as claimed in claim 1 having two occluding barriers, one on each end of the central section.
3. An occlusion device as claimed in any preceding claim, which adopts a collapsed condition for the purposes of placement and an expanded condition thereafter. 5
4. An occlusion device as claimed in claim 3, wherein at least an upstream occluding barrier retains a substantially concave shape when the device adopts the expanded condition.
5. An occlusion device as claimed in any preceding claim comprising a supporting structure formed from shape memory alloy.
6. An occlusion device as claimed in any preceding claim which is formed substantially in the shape of two cones joined at the apices by said central section, with an occluding barrier being formed at the base region of at least one of the cones.
7. An occlusion device as claimed in claim 6, wherein said means for anchoring the device comprises retaining spikes on one of said cones. .1 11
8. An occlusion device as claimed in any preceding claim wherein the ratio of the overall length to the diameter of the occlusion barrier is between about 2:1 and 8:1.
9. An occlusion device as claimed in any preceding claim wherein the or each occluding barrier is formed from end caps of a suitable occluding material. An occlusion device as claimed in any preceding claim, wherein the or each occluding barrier is provided with a skirt of sealing elements. o OOSO 0 S@ 00 00. S S OS An occlusion device according to any preceding claim wherein the or each occluding barrier has an expanded barrier diameter of greater than about 4 or 0 @065 0 S 0 a
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB9716497.4A GB9716497D0 (en) | 1997-08-05 | 1997-08-05 | Occlusion device |
| GB9716497 | 1997-08-05 | ||
| PCT/GB1998/002344 WO1999007292A1 (en) | 1997-08-05 | 1998-08-05 | Occlusion device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU8638498A AU8638498A (en) | 1999-03-01 |
| AU745168B2 true AU745168B2 (en) | 2002-03-14 |
Family
ID=10816977
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU86384/98A Ceased AU745168B2 (en) | 1997-08-05 | 1998-08-05 | Occlusion device |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US6419686B1 (en) |
| EP (1) | EP1018948A1 (en) |
| JP (1) | JP2001513353A (en) |
| AU (1) | AU745168B2 (en) |
| GB (1) | GB9716497D0 (en) |
| WO (1) | WO1999007292A1 (en) |
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- 1998-08-05 AU AU86384/98A patent/AU745168B2/en not_active Ceased
- 1998-08-05 US US09/463,766 patent/US6419686B1/en not_active Expired - Lifetime
- 1998-08-05 WO PCT/GB1998/002344 patent/WO1999007292A1/en not_active Application Discontinuation
- 1998-08-05 EP EP98937662A patent/EP1018948A1/en not_active Withdrawn
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| Publication number | Priority date | Publication date | Assignee | Title |
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| DE233303C (en) * | 1911-04-05 | |||
| US4710192A (en) * | 1985-12-30 | 1987-12-01 | Liotta Domingo S | Diaphragm and method for occlusion of the descending thoracic aorta |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2001513353A (en) | 2001-09-04 |
| WO1999007292A1 (en) | 1999-02-18 |
| US6419686B1 (en) | 2002-07-16 |
| EP1018948A1 (en) | 2000-07-19 |
| GB9716497D0 (en) | 1997-10-08 |
| AU8638498A (en) | 1999-03-01 |
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